Roche cobas infinity POC Add-on User guide

cobas

®

infinity POC IT solutions

POCT Management

User Guide

Publication version 1.1

Software version 1.0.1

2

Roche Diagnostics

cobas

®

infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1

Publication information

Publication version Software version Revision date Change description

1.0 1.0 July 2018 First version

1.1 1.0.1 September 2018 Update of supported iOS versions

y Revision history

Edition notice

This publication is intended for users of the cobas

®

infinity POC IT solutions application.

Every effort has been made to ensure that all the

information contained in this publication is correct at the

time of publishing. However, the manufacturer of this

product may need to update the publication information

as output of product surveillance activities, leading to a

new version of this publication.

General attention

To avoid incorrect results, ensure that you are familiar

with the instructions and safety information.

r Pay particular attention to all safety notices.

r Always follow the instructions in this publication.

r Do not use the software in a way that is not described

in this publication.

r Store all publications in a safe and easily retrievable

place.

Training

Do not carry out operation tasks or maintenance actions

unless you have received training from Roche

Diagnostics. Leave tasks that are not described in the

user documentation to trained Roche Service

representatives.

Images

The screenshots in this publication have been added

exclusively for illustration purposes. Configurable and

variable data in screenshots, such as tests, results, or

path names visible therein must not be used for

laboratory purposes.

Warranty

Any customer modification to the system renders the

warranty or service agreement null and void.

For conditions of warranty, contact your local sales

representative or refer to your warranty contract partner.

3

Roche Diagnostics

cobas

®

infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1

Copyright

License information

The cobas

®

infinity POC IT solutions application is

protected by contract law, copyright law, and

international treaties. The cobas

®

infinity POC IT

solutions application contains a user license between F.

Hoffmann-La Roche Ltd. and a license holder, and only

authorized users may access the application and use it.

Unauthorized use and distribution may result in civil and

criminal penalties.

Open Source and Commercial Software

The cobas

®

infinity POC IT solutions application may

include components or modules that are commercial or

open-source software. For copyright and other notices

and licensing information regarding such software

programs, see the electronic distribution included with

this product.

The cobas

®

infinity POC IT solutions application as a

whole may form a device regulated in accordance with

applicable laws. For more detailed information, refer to

the user documentation and labelling.

Please note that the respective authorization in

accordance with applicable laws lapses in case of any

unauthorized changes to the cobas

®

infinity POC IT

solutions application.

Trademarks

The following trademarks are acknowledged:

• ROCHE, ROCHE OMNI, ACCU-CHEK, COBAS B,

COBAS, and LIFE NEEDS ANSWERS are trademarks

of Roche.

• Roche and the Roche symbol are registered

trademarks of the Roche group.

All other trademarks are the property of their respective

owners.

Feedback

Every effort has been made to ensure that this

publication fulfils the intended use. All feedback on any

aspect of this publication is welcome and is considered

during updates. Contact your Roche representative,

should you have any such feedback.

Languages

The application is displayed in the language defined for

each user ID in the cobas IT 1000 application system.

4

Roche Diagnostics

cobas

®

infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1

Disclaimer

This publication may contain information and references

to products that may not be available in your country or

sold by Roche Diagnostics. This publication makes no

claims regarding the use or performance of those

products. Selected third-party products are available for

use with the cobas

®

infinity POC IT solutions

application.

The complete list of Roche Diagnostics and third-party

products available for use with the cobas

®

infinity POC

IT solutions application in the US can be found at http://

usdiagnostics.roche.com/cobasITdevices.

Other Roche Diagnostics or third-party products listed

within the software or manuals which are not listed at

http://usdiagnostics.roche.com/cobasITdevices are not

available for use with the cobas

®

infinity POC IT

solutions application in the US.

Contact addresses

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Distributed in USA by:

Roche Diagnostics

9115 Hague Road

Indianapolis, Indiana

USA

5Table of contents

Roche Diagnostics

cobas

®

infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1

Table of contents

Publication information 2

Contact addresses 4

Intended use 7

Symbols and abbreviations 7

Safety

1 Safety information

Safety classifications 15

System safety 16

Safety information for IT managers 17

Operation

2 Overview of the application

About the application 23

About the intended users 24

List of user profiles 25

Overview of the user interface 26

Specifications 28

3 Using the application

Frequently performed tasks 33

Managing devices 37

Managing operators 52

Managing certifications 59

Managing QC results 64

Managing reports 76

Configuration

4 Application settings

Configuring personal settings 87

Configuring devices 88

Glossary

Index

6

Roche Diagnostics

cobas

®

infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1

7

Roche Diagnostics

cobas

®

infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1

Intended use

cobas

®

infinity POC IT solutions is an application for

managing professional Point of Care testing. It is an

application that is intended to be connected with the

cobas IT 1000 application system, which collects POC

results and associated data. The cobas IT 1000

application system automatically receives data from POC

devices and delivers this data to a server application that

can be accessed via the cobas

®

infinity POC IT

solutions application via the hospital's network for review

by professional personnel.

This product is not intended for the diagnosis, screening,

monitoring, or treatment of patients.

Symbols and abbreviations

Product names

Except where the context clearly indicated otherwise, the

following product names and descriptors are used.

Product name Descriptor

cobas

®

infinity POC IT

solutions

application

cobas IT 1000 application

system

y Product names

Symbols used in the publication

Symbol Explanation

o

List item.

u

Related topics containing further information.

q

Tip. Extra information on correct use or useful

hints.

r

Start of a task.

I

Extra information within a task.

f

Result of an action within a task.

c

Frequency of a task.

n

Duration of a task.

y Symbols used in the publication

8

Roche Diagnostics

cobas

®

infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1

Symbol Explanation

d

Materials that are required for a task.

j

Prerequisites of a task.

u

Topic. Used in cross-references to topics.

p

Task. Used in cross-references to tasks.

w

Figure. Used in figure titles and cross-

references to figures.

y

Table. Used in table titles and cross-references

to tables.

z

Equation. Used in cross-references to

equations.

k

Code example. Used in code titles and cross-

references to codes.

y Symbols used in the publication

Symbols used on the product

Symbol Explanation

Catalogue number

Global Trade Item Number

Date of manufacture

Manufacturer

Consult instructions for use

y Symbols used on the product

Abbreviations

The following abbreviations are used.

9

Roche Diagnostics

cobas

®

infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1

Abbreviation Definition

ANSI American National Standards

Institute

POC Point of Care

POCC Point of Care coordinator

POCT Point of Care testing

VPN Virtual Private Network

y Abbreviations

10

Roche Diagnostics

cobas

®

infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1

Roche Diagnostics

cobas

®

infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1

Safety

1 Safety information......................................................................................... 13

13

Table of contents

Roche Diagnostics

cobas

®

infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1

Safety information

In this chapter

1

Safety classifications............................................................. 15

System safety........................................................................... 16

Safety information for IT managers................................. 17

1 Safety information

14

Table of contents

Roche Diagnostics

cobas

®

infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1

1 Safety information

15Safety information

Roche Diagnostics

cobas

®

infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1

Safety classifications

The safety information applies to the system and is listed

in accordance with ANSI Z535.6-2011. The Danger safety

classification to indicate a situation that results in injury

or death is not applicable to this system and is therefore

not listed.

WARNING!

Warning

r Indicates a potentially dangerous situation which, if

ignored, may lead to fatal or severe injuries.

CAUTION!

Caution

r Indicates a potentially dangerous situation which, if

ignored, may lead to injuries and/or damage to

property.

NOTICE!

NOTICE

r Indicates a message not related to personal injury.

1 Safety information

16 System safety

Roche Diagnostics

cobas

®

infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1

System safety

Failure to observe the safety information may result in

incorrect results, data corruption, and data losses.

CAUTION!

Incorrect or corrupt data due to unauthorized

access

Data security is breached if unauthorized users have

access to your user name and password.

r Use strong passwords.

r Always enter your password unobserved.

r Do not write down your password.

r Never write down the password in a contact form, in

an address book or in a file on the computer.

r Do not disclose your password to anyone. Roche

never asks you for your password.

r If you ever disclose your password to anyone, change

it immediately after.

r If you think anyone else has access to your account,

contact your Roche Service representative

immediately.

NOTICE!

Access to wrong device

Delayed troubleshooting or unnecessary maintenance of

a device accessed remotely.

r When you access a device remotely, check that the IP

address displayed corresponds to the one configured

for the device.

1 Safety information

17Safety information

Roche Diagnostics

cobas

®

infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1

Safety information for IT managers

The IT manager of your organization should ensure that

the following safety measures are implemented.

Data security

CAUTION!

Monitor the system for suspicious activity and

report suspected compromise

If you find any of the typical signs of malicious software

or unauthorized access to the system (unexpected

warning messages, files, or log entries like multiple

failed logon attempts; significantly degraded user

interface performance; seemingly random crashes of the

system; automated typing of text; and so on), the

following recommendations are essential:

r Physically disconnect the system from the network.

r Contact the IT responsible in your organization to

report and verify the finding.

r Mistrust results produced while the system has been

compromised.

r Contact your Roche Service representative to initiate

the system recovery.

1 Safety information

18 Safety information for IT managers

Roche Diagnostics

cobas

®

infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1

CAUTION!

Data loss or unavailability of the system due to

malicious software or unauthorized system access

Malicious software or unauthorized system access can

result in data loss or system unavailability.

To avoid infection by malicious software or the

unauthorized access and misuse of the system, the

following recommendations are essential:

r Make sure other computers and services on the

network (for example, the LIS, archiving share,

backup share, or service) are properly secured and

protected against malicious software and

unauthorized access.

r Restrict physical access to the system and all

attached IT infrastructure (computer, cables, network

equipment, and so on).

r Check all external storage devices, like CDs, DVDs, or

USB mass storage devices with an antivirus software

(on another computer) to ensure that they are free of

malicious software, before using them on the system.

r Use state-of-the-art security mechanisms (e.g. WPA2

EAP) to protect Wi-Fi connections.

r Allow only defined users to read and write encryption

keys (IIS App config / Windows Server Hardening).

r Allow only internet access to trusted web sites and

web services.

r Enable Data Execution Prevention for all applications

(Windows Server).

r Make sure to use secure channels to download

software updates of the system.

1 Safety information

Roche Diagnostics

cobas

®

infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1

Operation

2 Overview of the application....................................................................... 21

3 Using the application................................................................................... 31

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Roche cobas infinity POC Add-on User guide

Roche cobas infinity POC Add-on User guide

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